Urofollitropin (Intramuscular, Subcutaneous)

Urofollitropin injection is used to help women who are having trouble getting pregnant. This medicine is a synthetic hormone called follicle-stimulating hormone (FSH), which is made naturally by the pituitary gland in the body. FSH helps develop eggs in women's ovaries.

Urofollitropin will assist in developing and releasing eggs in women who cannot get pregnant due to ovulation issues and who have already taken a medicine to manage their pituitary gland.

This medicine is also used in women with healthy ovaries who are part of a fertility program known as assisted reproductive technology (ART). ART includes procedures like in vitro fertilization (IVF). Urofollitropin is used alongside human chorionic gonadotropin (hCG) in these procedures.

Urofollitropin is commonly used in women who have low FSH levels and high LH levels. Women with polycystic ovary syndrome often have these hormone levels and are treated with urofollitropin to make up for the low FSH. Many women receiving urofollitropin have already tried clomiphene (e.g., Serophene) without success in getting pregnant. Urofollitropin may also be used to stimulate the ovary to produce multiple follicles, which can then be collected for gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

This medicine is available only with a prescription from your doctor.

It is very important for your doctor to check your progress at regular visits to ensure that the medicine is working properly and to monitor for unwanted effects. Blood and urine tests, as well as ultrasound examinations, are needed to check for any unwanted effects caused by this medicine.

Call your doctor immediately if you think you might be pregnant while using this medicine. You may have a higher risk of an ectopic pregnancy or miscarriage if you become pregnant while undergoing IVF procedures. An ectopic pregnancy can be serious and life-threatening. It can also lead to issues that may make it harder for you to get pregnant in the future.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you experience a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

If your doctor has asked you to track your basal body temperature (BBT) daily, make sure you know how to do this. Follow your doctor's instructions carefully.

This medicine may increase your risk of a condition with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious condition that can be life-threatening. Call your doctor immediately if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble breathing.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This risk is higher in people who already have heart disease. Contact your doctor right away if you experience chest pain, tightness in the chest, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble breathing, sudden difficulty breathing at night, or unusual swelling in your ankles or legs. These could be signs of serious heart problems or blood clots.

This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Discuss this possibility with your doctor before starting this medicine.

This medicine may increase your risk of ovarian cancer if you have received it more than once to get pregnant. Talk to your doctor about this risk.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it versus the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other types of allergies, like those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of urofollitropin injection in children. Safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies on the effects of urofollitropin injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime, as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Adrenal gland problems, uncontrolled or
• Cysts in the ovaries or enlarged ovaries or
• High levels of FSH or
• Pituitary gland problems, uncontrolled or
• Thyroid gland problems, uncontrolled or
• Tumor in the brain (in the hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—This medicine should not be used in patients with these conditions.

• Blood clots (for example, pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Lung or breathing problems or
• Ovarian torsion (twisting of the ovary), history of or
• Stroke, or history of—Use with caution. This may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Abdominal or pelvic pain
• bloating (mild)

Less common or rare

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• chest pain or trouble breathing
• decreased amount of urine
• feeling of indigestion
• headache, sudden and severe
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath or wheezing
• skin rash or hives
• swelling of the arms or lower legs
• weight gain (rapid)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

Less common or rare

• Breast tenderness
• diarrhea (mild)
• headache
• hot flashes
• nausea
• redness, pain, or swelling at the injection site
• vomiting

After you stop using this medicine, it may still cause some side effects that need attention. During this time, check with your doctor right away if you notice the following side effects:

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• swelling of the lower legs
• weight gain (rapid)

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Fertinex

Pharmacologic Class: Human Follicle Stimulating Hormone

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under the skin or into a muscle.

Urofollitropin is used with another hormone called human chorionic gonadotropin (hCG). At the proper time, your doctor or nurse will give you this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You might be taught how to give your medicine at home. If you are using this medicine at home:

• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you understand and carefully follow your doctor's instructions on how to give yourself an injection, including the proper use of a needle and syringe.
• Check the solution in the vial. It should be clear and colorless. If it is cloudy, discolored, or contains large particles, do not use it.
• Do not inject more or less of the medicine than your doctor ordered.
• You will be shown the body areas (eg, stomach) where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will prevent skin problems.
• Use a new needle and syringe each time you inject your medicine.
• It is very important that you keep track of each dose you inject. Your doctor or nurse will help you with this.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form: For becoming pregnant while having a condition called polycystic ovary syndrome: Adults—75 International Units (IU) injected under the skin or into a muscle once a day for 7 or more days. Your doctor will give you another medicine called chorionic gonadotropin (hCG) the day after the last dose. Your doctor will increase your dose to 150 IU per day for another 7 or more days, if needed. Children—Use is not recommended. For induction of ovulation in women: Adults—At first, 150 International Units (IU) injected under the skin or into a muscle once a day for 5 days in the first cycle of treatment. Your doctor will adjust your dose after 5 days, if needed. However, the dose is usually not more than 450 IU per day. Do not use this medicine for more than 12 days. Children—Use is not recommended. For women with healthy ovaries undergoing assisted reproductive technology (ART): Adults—At first, 225 International Units (IU) (150 IU of Bravelle® and 75 IU of Menopur® or 75 IU of Bravelle® and 150 IU of Menopur®) injected under the skin once a day. Your doctor will adjust your dose after 5 days, if needed. However, the dose is usually not more than 450 IU per day. Do not use this medicine for more than 12 days. Children—Use is not recommended.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unused medicine in the refrigerator or at room temperature, protect from light. After mixing, use it immediately. Throw away any unused mixed medicine.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.